Latest News in the pharma Industry

Policy & Regulation

Novartis receives three new FDA approvals for the expanded use of Ilaris

Novartis receives three new FDA approvals for the expanded use of Ilaris

23 Sep 2016

Ilaris is the first and only US FDA-approved biologic treatment for patients with TRAPS, HIDS/MKD and FMF disease.

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FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

22 Sep 2016

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EMA validates BMS’s type II variation application for Opdivo in advanced form of bladder cancer

EMA validates BMS’s type II variation application for Opdivo in advanced form of bladder cancer

20 Sep 2016

Extends the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

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FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

19 Sep 2016

Approval given to EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 mg/kg for the treatment of DMD in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.

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District Court issues ruling in Hatch Waxman Case regarding Shire’s Lialda

District Court issues ruling in Hatch Waxman Case regarding Shire’s Lialda

18 Sep 2016

Shire to consider appeal.

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Glyxambi approval recommended by CHMP for adults with type 2 diabetes in the EU

Glyxambi approval recommended by CHMP for adults with type 2 diabetes in the EU

18 Sep 2016

Glyxambi is a single tablet that combines Jardiance and Trajenta and has been shown to improve blood sugar control in adults with type 2 diabetes.

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FDA advisory committees recommend to remove boxed warning in labeling for Pfizer’s smoking cessation therapy, Chantix

FDA advisory committees recommend to remove boxed warning in labeling for Pfizer’s smoking cessation therapy, Chantix

15 Sep 2016

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Santalis Pharmaceuticals issued patent for the use of sandalwood oil to treat cancers

Santalis Pharmaceuticals issued patent for the use of sandalwood oil to treat cancers

12 Sep 2016

Patent covers East Indian sandalwood oil-containing compositions that can be used to treat a variety of cancers.

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Dechra receives FDA approval for first US generic entrant antibiotic

Dechra receives FDA approval for first US generic entrant antibiotic

11 Sep 2016

Is the first registration Dechra has achieved through Putney's development pipeline since it acquired the US-based business

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Orphan Drug Designation granted to nintedanib for treatment of systemic sclerosis

Orphan Drug Designation granted to nintedanib for treatment of systemic sclerosis

9 Sep 2016

Designation also includes the associated interstitial lung disease.

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Lilly and AstraZeneca receive FDA Fast Track designation for AZD3293

Lilly and AstraZeneca receive FDA Fast Track designation for AZD3293

22 Aug 2016

AZD3293 is an investigational treatment for early Alzheimer's disease

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FDA pproves Pfizer's Troxyca ER Capsules CII with abuse-deterrent properties for the management of pain

FDA pproves Pfizer's Troxyca ER Capsules CII with abuse-deterrent properties for the management of pain

21 Aug 2016

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